Clinical Benefit Rate (CBR) [ Time Frame: Baseline; every 6 weeks for the first 36 weeks and then every 12 weeks until disease progression. The maximum time participants were followed was 11.07 months. ] [ Designated as safety issue: No ]

CBR is defined by the percentage of participants achieving either a confirmed tumor reponse or stable disease (SD) for at least 24 weeks. Response Criteria in Solid Tumors (RECIST) is a system for measuring tumor shrinkage or progression in terms of the longest dimensions of the tumor on imaging scans such as computerized tomography (CT). A "partial response" requires a decrease of 30% or more, "Progression" requires an increase of at least 20%, and "Stable disease" falls in between these two. All responses have a repeat assessment to confirm the response.

Secondary Outcome Measures:

Progression-Free Survival (PFS) [ Time Frame: Baseline; every 6 weeks for the first 36 weeks and then every 12 weeks until disease progression. The maximum time participants were followed was 11.07 months. ] [ Designated as safety issue: No ]

PFS is defined as the time from first dose date until the date of disease progression or death due to any reason, whichever occurs first.

Six Months Progression-Free Survival [ Time Frame: Baseline; every 6 weeks for the first 36 weeks and then every 12 weeks until disease progression. The maximum time participants were followed was 11.07 months. ] [ Designated as safety issue: No ]

Six Months Progression-Free Survival is defined as the percentage of surviving participants who are free of disease progression longer than six months (greather than 180 days) after the first start date of study treatment.

Time to Response [ Time Frame: Baseline; every 6 weeks for the first 36 weeks and then every 12 weeks until disease progression. The maximum time participants were followed was 11.07 months. ] [ Designated as safety issue: No ]

Time to response is defined as the time from first dose date until first documentation of disease response.

Duration of Response [ Time Frame: Baseline; every 6 weeks for the first 36 weeks and then every 12 weeks until disease progression. The maximum time participants were followed was 11.07 months. ] [ Designated as safety issue: No ]

Duration of response is defined as the time of first documentation of disease response until the date of disease progression or death due to breast cancer, whichever occurs first.

Central Nervous System as First Site of Relapse [ Time Frame: Baseline; every 6 weeks for the first 36 weeks and then every 12 weeks until disease progression. The maximum time participants were followed was 11.07 months. ] [ Designated as safety issue: No ]

Number of participants who have Central Nervous System metastasis as the first site of relapse. CT, Magnetic Resonance Imaging, etc. were used for the assessment.

• If recurrent disease is restricted to a solitary lesion, its neoplastic nature should be confirmed by cytology or histology.

Documented overexpression of Her2(ErbB2) of IHC 3+ or FISH positive, in primary or metastatic tumor tissue is required for enrollment into the study; by local testing or central laboratory testing determined by country of residence. NB. Approximately, 51 subjects will be enrolled in a single stage design to test for efficacy in women from China and Hong Kong. Due to the fact that trastuzumab is not commonly prescribed in China and Hong Kong, the current study allows up to 40% of subjects who are trastuzumab naïve to be enrolled.

Prior therapies must include at minimum a taxane and/or anthracycline and may include trastuzumab if available; other prior regimens are not limited except capecitabine and ErbB1/Erbb2 inhibitors other than trastuzumab. Chemo regimen requirements are as follows:

Radiotherapy as palliative treatment for painful metastatic disease is permitted but must have been stopped within 2 weeks prior to initiation of any investigational treatment. All subjects must have recovered from all radiotherapy related toxicities prior to initiation of any investigational treatment. The site of radiotherapy must not be used as a site of measurable disease;

Cardiac ejection fraction within institutional range of normal as measured by echocardiogram. MUGA scans will be accepted in cases where an echocardiogram cannot be performed or is inconclusive;

ECOG Performance Status of 0 to 1;

Life expectancy of ≥ 12 weeks;

Able to swallow and retain oral medication;

Women with potential to have children must be willing to practice acceptable methods of birth control during the study;

Willing to complete all screening assessments as outlined in the protocol;

Adequate organ function as defined by the Table of Baseline Laboratory Values

Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Subjects with ulcerative colitis are also excluded;

History of other malignancy. However, subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma, are eligible;

Concurrent disease or condition that would make the subject inappropriate for study participation, or any serious medical disorder that would interfere with the subject's safety;

Uncontrolled infection;

Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent;

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00508274